ADHD (Attention Deficit Hyperactivity Disorder) after Surgery for Congenital Hear

先天性听力手术后 ADHD（注意力缺陷多动障碍）

• 批准号: 7126959
• 负责人: VICTORIA L VETTER
• 金额: $ 49.65万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-13 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7126959
• 关键词: adolescence (12-20); age difference; attention deficit disorder; cardiovascular disorder therapy; central nervous system stimulants; clinical research; clinical trials; congenital heart disorder; cooperative study; disease /disorder proneness /risk; drug adverse effect; drug screening /evaluation; early experience; genetic susceptibility; heart /lung bypass; heart function; heart surgery; human subject; human therapy evaluation; middle childhood (6-11); patient oriented research; pediatric pharmacology; pediatrics; postoperative complications; postoperative state

DESCRIPTION (provided by applicant): Over the past decade the survival of children with congenital heart disease (CHD) has improved significantly, leading to an increasing number of survivors. Recognized sequelae of surgery for congenital heart surgery include residual hemodynamic abnormalities and arrhythmias. It is now being recognized that the neurodevelopmental sequelae of this type of surgery are substantial. Specifically, many school age children are challenged because of problems with inattention and hyperactivity; that is, they appear to have attention deficit hyperactivity disorder (ADHD). There is evidence that ADHD is more prevalent in the post surgery CHD patients than in the general population. In addition, the CHD-ADHD patients seem to be under treated. Thus, the primary aims of this study include 1) to determine the prevalence of ADHD in the population of children with CHD undergoing surgery using cardiopulmonary bypass in infancy or early childhood; 2) to compare the prevalence rates of ADHD associated with age of exposure to cardiopulmonary bypass as well as the effect of multiple exposures to CPB and different adjunctive support techniques that may be utilized; 3) to identify and compare the variety of patient related, operative and postoperative risk factors that could affect the likelihood of developing ADHD, including type of congenital heart defect, genetic substrate, surgical procedure required, operative factors, and perioperative events; and 4) to test the safety and efficacy of stimulant medications used to treat ADHD in a postoperative cardiac population. While studies suggest that many of these children have ADHD and could potentially benefit from the standard stimulant drug therapy effective in most of the population, concerns over cardiac safety has severely limited its use in children with heart disease. As no safety studies of the stimulant drugs in this population have been attempted, we propose a randomized double blind placebo controlled trial of the two most commonly used stimulant medications to determine their efficacy and true level of risk in postoperative cardiac children. This information will allow clinicians to use these potentially effective drugs safely in appropriate cardiac patients, improving the quality of life for these children with special needs. The Children's Hospital of Philadelphia (CHOP) Cardiology Division and Cardiac Center have a distinguished history of clinical innovation and excellence in cardiac care, a high volume program with expertise is all areas of pediatric cardiology and cardiothoracic surgery. The faculty of the CHOP and Cardiac Center are experienced investigators in multicenter clinical trials and studies. The institutional strengths and infrastructure support clinical investigations and enhance the likelihood that the aims and long term goals of the Pediatric Heart Network will be achieved. (End of Abstract).

描述（由申请人提供）： 在过去的十年中，先天性心脏病（CHD）儿童的生存率显着提高，导致幸存者数量不断增加。先天性心脏病手术公认的后遗症包括残余血流动力学异常和心律失常。现在人们认识到这种手术的神经发育后遗症是严重的。具体而言，许多学龄儿童因注意力不集中和多动等问题而面临挑战；也就是说，他们似乎患有注意力缺陷多动障碍（ADHD）。有证据表明，ADHD 在术后 CHD 患者中比在一般人群中更常见。此外，CHD-ADHD 患者似乎没有得到充分的治疗。因此，本研究的主要目的包括 1) 确定在婴儿期或幼儿期接受体外循环手术的先心病儿童群体中 ADHD 的患病率； 2) 比较与体外循环暴露年龄相关的 ADHD 患病率，以及多次体外循环和可能使用的不同辅助支持技术的影响； 3) 识别和比较可能影响 ADHD 发生可能性的各种患者相关、手术和术后危险因素，包括先天性心脏病类型、遗传基础、所需手术程序、手术因素和围手术期事件； 4) 测试用于治疗心脏病术后多动症的兴奋剂药物的安全性和有效性。虽然研究表明，其中许多儿童患有多动症，并且可能受益于对大多数人群有效的标准兴奋剂药物治疗，但对心脏安全性的担忧严重限制了其在患有心脏病的儿童中的使用。由于尚未尝试对该人群中的兴奋剂药物进行安全性研究，因此我们建议对两种最常用的兴奋剂药物进行随机双盲安慰剂对照试验，以确定它们对术后心脏病儿童的疗效和真实风险水平。这些信息将使临床医生能够在适当的心脏病患者中安全地使用这些潜在有效的药物，从而改善这些有特殊需要的儿童的生活质量。费城儿童医院 (CHOP) 心脏病科和心脏中心在临床创新和卓越的心脏护理方面拥有悠久的历史，拥有涵盖儿科心脏病学和心胸外科所有领域的专业知识的大容量项目。 CHOP 和心脏中心的教职人员都是多中心临床试验和研究方面经验丰富的研究人员。机构优势和基础设施支持临床研究，并提高实现儿科心脏网络的目标和长期目标的可能性。 （摘要结束）。